A Prospective, Randomized Study of Cataract Surgery With the Assistance of the OptiMedica Femtosecond Laser System Compared to Standard Surgical Procedure of Continuous Curvilinear Capsulorhexis and Ultrasonic Phacoemulsification
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Deviation From Intended Capsulotomy Diameter
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the OptiMedica Femtosecond Laser System to perform surgical maneuvers used in the treatment of subjects with cataracts. The safety and efficacy will be compared to the standard surgical procedure of continuous curvilinear capsulorhexis (CCC) and ultrasonic phacoemulsification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to comply with the treatment/follow-up schedule and requirements
- •Able to understand and provide written Informed Consent
- •ETDRS (Early Treatment of Diabetic Retinopathy Study) visual acuity equal to or worse than 20/32 (best corrected)
- •Age between 50 and 80 years old
- •Pupil dilates to at least 7 mm
- •Subject able to fixate
- •Grade 1-4 nuclear sclerotic cataract (Lens Opacities Classification System - LOCS III)
- •Axial length between 22 and 26 mm
排除标准
- •Pregnant, intending to become pregnant during course of the study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding
- •Participation in a study of another device or drug within 3 months prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria
- •Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study or for which cataract surgery is contraindicated
- •Anterior chamber depth (anterior corneal surface to anterior capsule margin) less than 2.5 mm via IOL Master (Zeiss).
- •History of prior ocular surgery
- •History of ocular trauma
- •Co-existing ocular disease affecting vision
- •History or current use of alpha-1 antagonist medication (e.g., Flomax)
- •Known sensitivity to planned concomitant medications
研究组 & 干预措施
FS Laser Surgery
For femtosecond laser-assisted cataract surgery group (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device. If necessary, ultrasound (U/S) phacoemulsification will also be applied to facilitate removal of the crystalline lens during cataract surgery.
干预措施: FS Laser Surgery (Device)
CCC Surgery
For the continuous curvilinear capsulorhexis (CCC) group (CCC Surgery), subjects will receive the standard of care for CCC and U/S phacoemulsification surgery to facilitate removal of the crystalline lens during cataract surgery.
干预措施: CCC Surgery (Procedure)
结局指标
主要结局
Deviation From Intended Capsulotomy Diameter
时间窗: Day of Surgery
Capsulotomy diameter measured during surgery for both the experimental and control groups.
次要结局
- Cumulative Dissipated Energy (CDE)(Day of Surgery)